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OpenTrials
Completed

NCT Number: NCT01506336

Masitinib in Patients With Gastro-Intestinal Stromal Tumour Resistant to Imatinib

The objective is to compare efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with gastro-intestinal stromal tumor resistant to imatinib.

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Key information

Conditions

Gastro Intestinal Stromal Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute Gustave Roussy (IGR)

Villejuif, 94815, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological proven, metastatic, or locally advanced and non-operable GIST
  • Measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according RECIST criteria
  • C-kit (CD117) positive tumors detected immuno-histochemically and documented mutation of c-kit at any time if available
  • Patients resistant to imatinib at dose of 400 mg/day

Exclusion criteria

  • Patient treated for a cancer other than GIST cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
  • Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis

Treatment and study plan

Masitinib

Drug

masitinib 12 mg/kg/day

Sunitinib

Drug

sunitinib 50 mg/day

Primary outcomes

  1. overall progression free survival

    Time frame: up to 36 weeks

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 weeks

Secondary outcomes

  1. overall survival

    Time frame: up to 36 weeks

    From date of randomization until the date of death from any cause, assessed up to 36 weeks

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized, Open-label, Active Controlled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of Masitinib at 12 mg/kg/Day to Sunitinib at 50 mg/Day in Treatment of Patients With Gastro-intestinal Stromal Tumor Resistant to Imatinib

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 10, 2012
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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